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Clinical Trials/NCT01835886
NCT01835886CompletedNot Applicable

Study to Assess if Ability to Ascend and Descend Stairs Within 30 Seconds Will Prove to be a Reliable and Valid Outcome Measure in Individuals With Pulmonary Disease

Beth Israel Medical Center1 site in 1 country29 target enrollmentStarted: March 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
29
Locations
1
Primary Endpoint
Timed Stair Climbing Test Assessing Change Between Initiation and at Completion of Pulmonary Rehabilitation Sessions

Study Overview

Brief Summary

To determine if stair climbing can be used as a measure of progress in persons with pulmonary disease.

Detailed Description

Protocol Title: The Reliability and Validity of the Timed Stair Climbing Test (TSCT) as an Outcome Measure in Individuals with Pulmonary Disease.

Background An important part of pulmonary rehabilitation is the ability to document progress. Commonly used outcome measures include walking tests like the Six Minute Walk Test (6MWT) and the Shuttle Walk Test, MET levels and questionnaires. A recent study by Annegarn1 et al., analyzed responses from 820 Chronic Obstructive Pulmonary Disease (COPD) patients. While 35% of respondents cited stair climbing as a problematic Activity of Daily Living (ADL), there are very few studies looking at stair climbing ability as an outcome measure.

Step tests using a riser and metronome have long been used as a fitness measure for healthy subjects but can be challenging to administer to a non healthy population and do not mimic the challenge of actually mounting a series of steps. Many of the existing stair climbing studies which use actual stairs for testing are distance based and examine stair climbing as a predictor for outcomes following lung surgery. One study conducted by Randolph2 et al., attempted to compare stair climbing ability and Pulmonary Function Tests (PFTs) as predictors of post-thoracotomy outcomes. Brunelli3 et al., looked at stair climbing as a useful predictor of cardiopulmonary complications following lung resection. Both studies concluded that the stair climbing test was clinically useful.

Bean4 developed a stair climbing test called the Stair Climb Power Test that incorporated an element of time by asking subjects to climb a staircase of ten stairs as quickly and safely as possible and looked at the relationship between muscle strength and functional performance.

The Six Minute Walk Test is well established as a valid and reliable outcome measure for this population5. A study by Dreher6 et al., in 2008 attempted to compare a stair climbing test with the Six Minute Walk Test. Using a randomized cross-over design, they looked at sixteen COPD patients and found that pathophysiological changes during a six minute walk test did not anticipate changes found during stair climbing in patients with severe COPD.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •This study population will consist of patients with documented pulmonary disease who underwent a course of pulmonary rehabilitation at The Alice Lawrence Center for Health and Rehabilitation consisting of 10 or more sessions

Exclusion Criteria

  • •Patients who have orthopedic or neurological conditions (significant limitations in ambulation or stair climbing) that limit participation in pulmonary rehabilitation

Arms & Interventions

Performs stair-climbing

Experimental

Performs stair climbing

Intervention: Patients will ascend and descend a flight of 10 steps (Other)

Outcomes

Primary Outcomes

Timed Stair Climbing Test Assessing Change Between Initiation and at Completion of Pulmonary Rehabilitation Sessions

Time Frame: Ascent and descent of stairs will be assessed prior to initiating and following 18 to 36 weeks of outpatient pulmonary rehabilitation

Subjects will be asked to ascend and descend a flight of 10 steps both at initiation and completion of a course of pulmonary rehabilitation.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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